Brief Behavioral Treatment for Anxiety in Young Children (PLET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
Adam Lewin, University of South Florida
ClinicalTrials.gov Identifier:
NCT02051192
First received: January 29, 2014
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

Behaviorally and cognitive-behaviorally based therapeutic techniques (BT; CBT) that incorporate exposure therapy useful for treatment of anxiety disorders among typically developing children. Although a large amount of data demonstrate the effectiveness of of BT and CBT approaches for treating anxious youth, there is a gap in the literature for the effectiveness of these approaches for children under the age of seven. Evidence increasingly suggests that family factors such as accommodation and parenting style contribute significantly to the presence of anxiety symptoms as well as treatment outcomes, particularly in young children. These findings stress the importance of using a treatment approach in which parents are directly involved in education, parent training, and generalization of treatment effects. Therefore, this study aims to evaluate a new treatment program, parent-led behavioral treatment, for children ages 3 to 7 years of age who have a principal anxiety disorder diagnosis.


Condition Intervention Phase
Obsessive-compulsive Disorder
Social Phobia
Generalized Anxiety Disorder
Specific Phobia
Separation Anxiety Disorder
Selective Mutism
Anxiety Disorder, Not Otherwise Specified
Behavioral: Parent-Led Exposure Therapy
Other: Treatment As Usual
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Brief Behavioral Treatment for Anxiety in Young Children

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Pediatric Anxiety Rating Scale [ Time Frame: after 5 weeks of treatment ] [ Designated as safety issue: No ]
    The PARS is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week.

  • Clinical Global Impression - Severity [ Time Frame: After 5 weeks of treatment ] [ Designated as safety issue: No ]
    The CGI-S is a 7-point clinician rating of severity of psychopathology anchored by 1 ("no illness") and 7 ("very severe").

  • Clinical Global Improvement [ Time Frame: After 5 weeks of treatment ] [ Designated as safety issue: No ]
    The CGI is a 7-point rating of treatment response anchored by 1 ("very much improved) and 7 ("very much worse"). Youth being rated by the IE as 1 ("very much improved") and 2 ("much improved") will be considered treatment responders.


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parent-Led Exposure Therapy (PLET)
Therapists will work with families for 10 sessions, twice weekly. The first treatment session will be a 90 minute parent only psychoeducation and treatment preparation session. Each subsequent session will last up to 60 minutes and will consist of exposure therapy using developmentally appropriate modulated behavioral approaches such as Participant modeling (PM) and Reinforced practice (RP).
Behavioral: Parent-Led Exposure Therapy
Therapists will work with families for 10 sessions, twice weekly. The first treatment session will be a 90 minute parent only psychoeducation and treatment preparation session. Each subsequent session will last up to 60 minutes and will consist of exposure therapy using developmentally appropriate modulated behavioral approaches such as Participant modeling (PM) and Reinforced practice (RP).
Other Name: Brief Behavioral Treatment for Anxiety in Young Children
Active Comparator: Treatment As Usual
Patients randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice.
Other: Treatment As Usual
Patients randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice. These participants may also elect to receive no treatment at all during the TAU period.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatient children between the ages 3-7 years.
  • Meets DSM-IV criteria for a primary diagnosis of an anxiety disorder or achieves a minimum score of 12 Pediatric Anxiety Rating Scale (PARS)
  • Child has a PPVT IV SS > 80.
  • Patients with co-morbid depression, ADHD, tic disorder or disruptive behavior disorders will be included as long as anxiety is primary (i.e., most impairing/distressing).

Exclusion Criteria:

  • • (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.

    • Receiving concurrent psychotherapy, social skills training, or behavioral interventions (e.g., applied behavior analysis). Families will have the option of discontinuing such services to enroll in the study. Those randomized treatment as usual (TAU) will be able to continue or initiate psychosocial interventions (psychotherapy, social skills training, applied behavior analysis, or family therapy) whereas those randomized to PLET will not receive these interventions concurrent with PLET.
    • Any change in established psychotropic medication (e.g., antidepressants, anxioloytics, antipsychotics, stimulants) within 10 weeks before study. Those randomized to TAU may make medication changes following randomization, including starting a medication; those randomized to PLET will remain stable on medications during the study.
    • Absence of language.
    • A formal diagnosis of mental retardation or autism spectrum disorder.
    • Unwillingness of parents to make the commitment to accompany their child for multiple study visits, unwillingness to take part in randomization, inability to attend sessions twice weekly as therapist availability allows, inability to attend assessment visits.
    • Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051192

Contacts
Contact: Adam B. Lewin, Ph.D. 7277678230 alewin@health.usf.edu

Locations
United States, Florida
Rothman Center for Pediatric Neuropsychiatry - University of South Florida Recruiting
St. Petersburg, Florida, United States, 33701
Principal Investigator: Adam B. Lewin, Ph.D.         
Sub-Investigator: Brittany M. Rudy, Ph.D.         
Sub-Investigator: Sophia Zavrou, Psy.D.         
Sponsors and Collaborators
University of South Florida
  More Information

No publications provided

Responsible Party: Adam Lewin, Assistant Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT02051192     History of Changes
Other Study ID Numbers: PLET-13-0634
Study First Received: January 29, 2014
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Social phobia
Specific phobia
obsessive-compulsive disorder
Generalized anxiety disorder
Separation anxiety disorder
Selective Mutism
Anxiety Disorder, Not Otherwise Specified
Counseling
Behavioral therapy
Psychotherapy
Exposure
Young Children

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Phobic Disorders
Anxiety, Separation
Mental Disorders
Pathologic Processes
Personality Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on September 30, 2014